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Initiation and continuation of randomized trials after the publication of a trial stopped early for benefit asking the same study question: STOPIT-3 study design

Prutsky, Gabriela J. and Domecq, Juan Pablo and Erwin, Patricia J. and Briel, Matthias and Montori, Victor M. and Akl, Elie A. and Meerpohl, Joerg J. and Bassler, Dirk and Schandelmaier, Stefan and Walter, Stephen D. and Zhou, Qi and Coello, Pablo Alonso and Moja, Lorenzo and Walter, Martin and Thorlund, Kristian and Glasziou, Paul and Kunz, Regina and Ferreira-Gonzalez, Ignacio and Busse, Jason and Sun, Xin and Kristiansen, Annette and Kasenda, Benjamin and Qasim-Agha, Osama and Pagano, Gennaro and Pardo-Hernandez, Hector and Urrutia, Gerard and Murad, Mohammad Hassan and Guyatt, Gordon. (2013) Initiation and continuation of randomized trials after the publication of a trial stopped early for benefit asking the same study question: STOPIT-3 study design. Trials, 14. p. 335.

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Official URL: http://edoc.unibas.ch/53540/

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Abstract

Randomized control trials (RCTs) stopped early for benefit (truncated RCTs) are increasingly common and, on average, overestimate the relative magnitude of benefit by approximately 30%. Investigators stop trials early when they consider it is no longer ethical to enroll patients in a control group. The goal of this systematic review is to determine how investigators of ongoing or planned RCTs respond to the publication of a truncated RCT addressing a similar question.; We will conduct systematic reviews to update the searches of 210 truncated RCTs to identify similar trials ongoing at the time of publication, or started subsequently, to the truncated trials ('subsequent RCTs'). Reviewers will determine in duplicate the similarity between the truncated and subsequent trials. We will analyze the epidemiology, distribution, and predictors of subsequent RCTs. We will also contact authors of subsequent trials to determine reasons for beginning, continuing, or prematurely discontinuing their own trials, and the extent to which they rely on the estimates from truncated trials.; To the extent that investigators begin or continue subsequent trials they implicitly disagree with the decision to stop the truncated RCT because of an ethical mandate to administer the experimental treatment. The results of this study will help guide future decisions about when to stop RCTs early for benefit.
Faculties and Departments:03 Faculty of Medicine > Departement Klinische Forschung > Clinical Epidemiology and Biostatistics CEB > Klinische Epidemiologie (Bucher H)
UniBasel Contributors:Kasenda, Benjamin
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:BioMed Central
ISSN:1745-6215
e-ISSN:1745-6215
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:05 Oct 2017 08:17
Deposited On:05 Oct 2017 08:17

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